Gima 33580 Owner's manual

Gima
Brand
Gima
Model
33580
Type
Owner's manual

This manual is also suitable for

Rev. 17 dated 10.03.2022
TITANOX
s.r.l.
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INSTRUCTIONS MANUAL
DRY HEAT STERILIZING UNIT MOD.
PASTEUR ELECTRIC
0476
Summary
0) INTENDED USE ............................................................................................................................................................... 2
1) SYMBOLS AND SAFETY WARNINGS ......................................................................................................................... 2
2) TECHNICAL SPECIFICATIONS .................................................................................................................................... 3
3) ENVIROMENTAL CONDITIONS ................................................................................................................................... 4
4) INSTALLATION .............................................................................................................................................................. 4
5) SAFETY WARNINGS ...................................................................................................................................................... 5
6) TIME – PROGRAMMED RUNNING .............................................................................................................................. 5
7) CONTINUOS – CYCLE RUNNING ................................................................................................................................ 5
8) ORDINARY MAINTENANCE ........................................................................................................................................ 6
9) PERIODIC MONTHLY MAINTENANCE ...................................................................................................................... 6
10) PERIODIC ANNUAL MAINTENANCE ..................................................................................................................... 6
11) PERMITTED USES AND FORBIDDEN USES .......................................................................................................... 6
12) DETACHABLE COMPONENT PARTS ..................................................................................................................... 6
13) SELLING OFF .............................................................................................................................................................. 6
14) **ATTENTION**......................................................................................................................................................... 6
15) WARRANTY CONDITIONS ....................................................................................................................................... 7
16) USEFUL LIFE ............................................................................................................................................................... 7
0) INTENDED USE
The device is designed to be used in sanitary environments for the purpose of sterilizing non-heat sensitive
medical and surgical instruments. The process of disinfection is based exclusively on the thermal destruction of
the microorganisms present upon the instruments at a typical temperature of about 180º C.
Effectively reaching a sterile state for the instruments inserted into the sterilizers depends upon multiple factors:
• The level of initial contamination of the instruments (total bacterial load);
• The type of contaminating microorganisms;
• The permeability of all the contaminated instrument parts by the hot air produced by the sterilizer.
For more information see the paragraph **ATTENTION** ahead.
The device must be used only and exclusively by healthcare professionals (doctors, paramedics,
nurses or similar) who are familiar with the principles of controlling sterilization processes in
general and dry heat sterilization processes in particular
Index
Pos.1 - Thermoregulator int. temp. 50210° C (±6°C) Pos.6 - Warning light “resistances”
Pos.2 – Prog. timer 2 hours or manual (±3°) Pos.7 - Air-inlets for air circulation
Pos.3 - Thermometer int. temp. 50200°C (±10°C) Pos.8 - Closure with key
Pos.4 - Connection plug with fuses Pos.9 - Silicone gasket
Pos.5 - Warning light “timer” or “manual” connected Pos.10 - Security thermostat 232°C (±8°C)
1) SYMBOLS AND SAFETY WARNINGS
READ INSTRUCTIONS
ATTENZIONE: ALTA TEMPERATURA
ATTENTION: TEMPERATURE ELEVEE
CAUTION: HOT SURFACE
ACHTUNG: HEISS
PRECAUTION
:
ALTA TEMPERATURA
ATTENZIONE: P R I M A D I A P R I R E T O G L I E R E LA T E N SIONE
C A U T I O N : D I S C O N N E C T V O L T A G E B E F O R E O PE N I NG
ATTENTION : A V A N T D’O U V R I R, E N L E V E R L A T E N S I O N
A C H T U NG: VOR DEM OFFNEN STROMVERSORGUNG UNTERBRECHEN
C U I D A D O: A N T E S D E A B R I R D E S C O N E C T AR LA TENSIÓN
C U I D A D
O:
A N T E S D E A B R I
R T I R A R A T E N S
 O
PROTECTION
BINDING-
C
LAMP
2) TECHNICAL SPECIFICATIONS
Models A3-213-400 A3-214-535 A3-215-670
Loaded Chamber
3 kg
4 kg
5
kg
External sizes:
Width
mm
570
705
835
Height
mm
400
475
555
Depth
mm
34
5
45
0
565
Internal sizes:
Width
mm
405
535
670
H
eight
mm
21
0
345
415
Depth
mm
25
5
320
420
Weights:
Net weight
13 kg
22 kg
3
5
kg
Gross weight
15 kg
25 kg
41
kg
Electrical Characteristics:
Nominal tension (Voltage)
230
V
230
V
230 V
Nominal power (Watt)
450 W
950
W
1
900
W
Nominal frequency (Hz)
50/60 Hz
50/60 Hz
50/60 Hz
Net
’
s fuses
(
mm 5
x20)
F5A
-
250 V
F5A
-
250 V
F10A
-
250V
The device is in conformity to electrical safety norms provided for by the normative institutes and supplied with bipolar plug
which assures perfect electrical grounding.
NON-COMPLIANCE WITH INSTRUCTIONS DESCRIBED IN THIS BOOKLET SHALL
FREE COMPANY TITANOX S.R.L. FROM ANY LIABILITY.
SYMBOLS MEANING
Warning!
See the annexed documentation
Use heat insulating gloves
Caution! Hot surface (max. 210 °C)
It points the Manufacturer’s name
This symbol, together with the year, points the production date
Keep away from sunlight
Keep in a cool, dry place
Medical Device
RAEE symbol to handle electrical and electronical devices wastes
Available operation:
TIME-PROGRAMMED: timer programmable up to 2 hours
CONTINUUOUS CYCLE: manual (without timer)
3) ENVIROMENTAL CONDITIONS
Ambient temperature from 5 to 40° C.
Relative humidity max. 80% for temperatures up to 31° C with linear decrease up to 50% at the temperature of
40° C condensing included.
Atmospheric Pressure from 500 to 1060 hPa.
Voltage supply variation not higher than 10%.
Value of transitory over-voltage in conformity to the installation category (which provides for 2500V).
4) INSTALLATION
The device has been calibrated and tested at factory and as such does not require any further calibration or
adjustments before installation and start-up.
Unpack the device and follow the next advices:
1. Position the device on a levelled flat, hard, and smooth surface, established with non-inflammable material.
2. Allow space not lower than 10 cm from walls and surrounding furniture.
3. Do not install the device nearby water sinks or similar to avoid contacts with water or substances which could
cause electrical short-circuit to the system.
4. Install the device in a well aerated location, not near windows or external doors which could cause an unnatural
circulation of the air inside the device and therefore compromise its correctly running.
5. Do not install the device nearby heat sources or near other electrical devices.
6. Install the device in such a way that the power cable is never twisted or bent, but it should connect to the socket
free and unhindered. Avoid to positioning the power cable nearby heat sources or other devices that shall cause
damage on it in a long run.
7. In the event the device is placed on a trolley, always check that the lower part of the device is not enclosed or
hindered, as to allow continuous and sufficient ventilation.
Once the device is correctly installed and power cable connected, it is ready for use.
5) SAFETY WARNINGS
• The device is designed for use in internal locations.
• The device is not designed for use in presence of gasses or explosive vapours.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation.
• No water or other liquids should be poured into device neither on its base.
• Before any cleaning or maintenance actions, the power cable must always first be removed.
• Make sure that the electrical system has electrical grounding and that it’s in conformity to the safety norms in
the country of installation.
• Do not remove any label or plate, in case of need, ask for more.
• Request only original spare parts cause in case of substitution with no original ones, there could be an increase
of electromagnetic emissions or a decreased of electromagnetic immunity of this equipment. This may vary the
performance and safety of the equipment.
• Portable RF communications equipment should be used no closer than 30 cm to any part of the sterilizer,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
• Emissions class and group: Class A Group 1; Insulation class: 1; IP20
• Do not open the door of the device until the thermometer of the internal temperature do not indicate a
temperature lower than 30°C.
• Medical devices, before being placed in the sterilizer, should be washed and dried. The residual water steam
may create deposits on the probes and resistances by altering the precision
6) TIME – PROGRAMMED RUNNING
1. Insert the supplied connection socket of the mains cable in the plug of the device
(Pos. 4) and the feeder- plug in the wall mains socket, after checking the voltage value.
2. Turn the thermoregulator knob (Pos. 1) and set the desired temperature. This operation shall always be carried
out when device is cold.
3. Place materials to be sterilized inside the device.
4. Lock up the door (Pos. 8).
5. Keep the air-inlets half-opened (Pos. 7) to allow a better circulation of the air inside the device and to distribute
the heat even to the corners and hidden spaces. Close the above air-inlets only at the end of the sterilization cycle
in order to seal the device and to keep the material inside in temperature for a long time
6. Set, by turning the timer knob (Pos. 2) anti-clockwise, the sterilization time adding necessary time in order to
bring the device and the material inside to the desired temperature. The necessary time to reach the temperature of
180°C is about 30 minutes in case of empty chamber sterilizer, and about 60 minutes with Loaded Chamber well
arranged on the trays. This operation switch on the warning light (Pos. 5) indicating that the device is working
and the warning light “resistance” (Pos. 6) indicating that the resistances are turned on in the circuit. The
graduated thermometer (Pos. 3) allows to check the progressive increase of the internal temperature. When the
internal temperature has reached the programmed value, the warning light “resistance” (Pos. 6) is turned off for
then, after brief time, again turned-on indicating the re-connection of the resistances in the circuit. This operation
allows to keep inside the device a constant temperature up to the end of the sterilization cycle. After programmed
time has elapsed, the device turns itself off automatically.
7) CONTINUOS – CYCLE RUNNING
The device has also a continuous cycle running. For use this kind of running proceed up to point 5 of the
procedure for time-programmed running described above. Turn, at this moment, the timer knob (Pos. 2) anti-
clockwise. The indefinite-time manual continuous-cycle is inserted with a click. To turn off the device, turn back
the timer know to position 0.
8) ORDINARY MAINTENANCE
Before initiating any maintenance operation, make sure that:
• the device is not connected to the power source.
• the device is at ambient temperature.
Keep the internal parts and the grid perfectly clean. Even though they may change colour and become brownish,
never use abrasive or inflammable products for cleaning them.
Keep the external parts perfectly clean that they must be always specular to prevent corrosion and dust.
9) PERIODIC MONTHLY MAINTENANCE
After removing the plug from the power socket, check that the fuses are not oxidised specially when the device is
not used for a long time or kept in a humid ambient.
The power socket should not change colour or oxidise. If that happens, replace it immediately.
The power cable must be integral, and it should not show cuts, abrasions or bending.
The resistances and the internal electrical system do not require any maintenance.
10) PERIODIC ANNUAL MAINTENANCE
It is recommended to carry out at least annually the verification of the leakage currents and the verification of the
earth conductor with an electrical safety tester in accordance with the requirements of EN 60601-1 or EN 62353.
Even if it is advisable for the user to provide a method of physical validation of the device upon installation and
routine checks (for example using biological indicators during each cycle), it is still recommended to check the
status of the devices at least annually, to control systems of the sterilizer, in particular the temperature control
system, to verify that the expected performance is maintained.
11) PERMITTED USES AND FORBIDDEN USES
The device must be used to sterilize metal materials whose point of melting is higher than 300°C (surgical
instruments, plates, and metal screw).
Inside the sterilizer place only metal containers without plastic parts and without textile material.
It is forbidden to place in the device items whose temperature of melting is lower than 300°C or it is not known to
the operator.
12) DETACHABLE COMPONENT PARTS
2 Internal shelves
1 Main cable
13) SELLING OFF
The sterilizing unit is made of various materials with mechanical, electro-mechanical and electronic parts.
The selling off has to be made according with the regulations in force in the utilizing Nation.
14) **ATTENTION**
Laboratory tests following a cycle of 120 minutes at 180ºC on Bacillus subtilis var niger ATCC 9372 spores
demonstrated the efficiency of the sterilizer.
Titanox does not guarantee and cannot ensure the effective achievement of the sterile state of the instruments
placed in the sterilizer, according to the definition of sterile medical instruments foreseen by the EN 556 Norms.
The user of the sterilizer therefore has the responsibility to conduct all of the confirmation procedures of the
sterilization process and the necessary verifications in order to ensure the effective completion of every single
sterilization cycle.
For this reason, in order to ensure a correct routine control of the sterilization cycle, it is recommended to use
biological indicators in the load to be sterilized, as prescribed by ISO 20857. In any case, it is the user's
responsibility to use a method that allows to unambiguously identify successfully sterilized and non-sterilized
devices.
15) WARRANTY CONDITIONS
1) The device is warranted for a period of one year from date of purchase.
2) Warranty covers the substitution or repairs free-of-charge of components with manufacturing defects.
3) The device will be repaired only at our factory. Charges, risks arising from the transport of the device shall be
on purchaser’s account.
4) In the event of repairs at purchaser’s home, purchaser shall be charged fixed call costs covering partial
reimbursement of travel and professional visit by personnel.
5) Warranty coverage excludes internal lighting, damages caused by carelessness of purchaser, incorrect and
improper uses and installations not conforming to warnings, indicated in these booklet instructions or in any case
results from phenomenon unrelated to the normal working of the device.
6) The warranty expires when the device is tampered with or repaired by unauthorised personnel.
7) It is excluded the substitution and the extension of the warranty following a breakdown.
8) It is excluded any compensation for damages direct or indirect of any nature to persons or objects arising from
use or suspension of use of the device.
9) The warranty expires immediately if the relative certificate shows alterations, erasing, or it is not issued or
convalidated by us. The certificate must accompany the device or handed to maintenance personnel for home-
repairs.
The manufacturing company Titanox S.r.l. is responsible for the safety, reliability, and performance of the device
if:
- the assembly, the additions, the re-setting, the modification, or repairs are carried out by personnel of Titanox
S.r.l.
- the electrical system to which it is connected conforms to safety norms in country of installation.
- the device is used in conformity to instructions of use and maintenance.
This liability expires immediately when the device is tampered with or repaired by unauthorised personal.
For any further requirements of spare parts, repairs or checks, it’s necessary contact directly the
manufacturer: TITANOX S.r.l. - Via Canove 2/A – Loc. Canove de’ Biazzi – 26038 Torre de’
Picenardi (CR) – Italia - Tel. (0039) 0375 394065 – Fax (0039) 0375 394067 communicating the
registration number of the device to repair.
All serious accidents concerning the medical device supplied by us must be reported to the
manufacturer and Competent Authority of the member State where your registered office is
located.
16) USEFUL LIFE
The useful life of the device is established in years 5 from the commissioning. For this period Titanox S.r.l.
guarantees the availability of spare parts and safe operation if the environmental and use conditions defined in the
instructions for use are respected by the user.
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Gima 33580 Owner's manual

Gima
Brand
Gima
Model
33580
Type
Owner's manual
This manual is also suitable for
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